A Study of Insulin Efsitora Alfa (LY3209590) Compared to Glargine in Adult Participants With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time (QWINT-1)

Type 2 Diabetes Clinical Trial

— QWINT-1  

Official title:

A Phase 3, Parallel-Design, Open-Label, Randomized Control Study to Evaluate the Efficacy and Safety of LY3209590 Administered Weekly Using a Fixed Dose Escalation Compared to Insulin Glargine in Insulin-Naïve Adults With Type 2 Diabetes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05662332
• Other study ID #: 18261
• Secondary ID: I8H-MC-BDCW
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: January 14, 2023
• Est. completion date: July 16, 2024

Study information

• Verified date: May 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study is to determine the efficacy and safety of insulin efsitora alfa (LY3209590) administered weekly using a fixed dose escalation compared to insulin glargine in adults with type 2 diabetes (T2D) who are starting basal insulin therapy for the first time.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 796
• Est. completion date: July 16, 2024
• Est. primary completion date: July 16, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have a diagnosis of T2D according to the World Health Organization criteria.

• Have an HbA1c of 7.0% to 10.0%, inclusive, at screening.

• Are on a stable treatment of at least 1 antihyperglycemic medication, for at least 3 months prior to screening, and willing to continue the stable treatment for the duration of the study.

• Are insulin naive

Exceptions:

• short-term insulin treatment for a maximum of 14 days, prior to screening, and

• prior insulin treatment for gestational diabetes.

Exclusion Criteria:

• Have a diagnosis of type 1 diabetes (T1D), latent autoimmune diabetes, or specific type of diabetes other than T2D, for example, monogenic diabetes, diseases of the exocrine pancreas, or drug induced or chemical-induced diabetes.

• Have a history of >1 episode of ketoacidosis or hyperosmolar state or coma requiring hospitalization within 6 months prior to screening.

• Have had severe hypoglycemia episodes within 6 months prior to screening.

• Have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c.

• Have had New York Heart Association Class IV heart failure or any of these cardiovascular conditions within 3 months prior to screening

• acute myocardial infarction

• cerebrovascular accident (stroke), or

• coronary bypass surgery.

• Have had gastric bypass (bariatric) surgery, restrictive bariatric surgery, for example Lap-Band, or sleeve gastrectomy within 1 year prior to screening

• Have had significant weight gain or loss within 3 months prior to screening, for example, =5%.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• T2D
• Type 2 Diabetes

Intervention

Drug:
• Insulin Efsitora Alfa
Administered SC
• Insulin Glargine
Administered SC

Locations

Country	Name	City	State
Argentina	Asociación de Beneficencia Hospital Sirio Libanés	Buenos Aires	Buenos Air
Argentina	Centro Médico Viamonte	Buenos Aires	Ciudad Aut
Argentina	CIPREC	Buenos Aires	Ciudad Autónoma De Buenos Aire
Argentina	Fundación Respirar	Buenos Aires
Argentina	Glenny Corp	Buenos Aires	Ciudad Aut
Argentina	Investigaciones Medicas Imoba Srl	Buenos Aires	Ciudad Autónoma De Buenos Aire
Argentina	Stat Research S.A.	Buenos Aires	Ciudad Aut
Argentina	CEMEDIAB	C.a.b.a.	Ciudad Aut
Argentina	Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada	Ciudad Autonoma de Buenos Aire	Ciudad Autónoma De Buenos Aire
Argentina	Centro de Investigaciones Metabólicas (CINME)	Ciudad Autónoma de Buenos Aire	Buenos Aires
Argentina	CENUDIAB	Ciudad Autónoma de Buenos Aire
Argentina	Centro Medico Privado San Vicente Diabetes	Cordoba	Córdoba
Argentina	CIPADI - Centro Integral de Prevencion y Atencion en Diabetes	Godoy Cruz	Mendoza
Argentina	Instituto de Investigaciones Clínicas Mar del Plata	Mar del Plata	Buenos Aires
Argentina	DIM Clínica Privada	Ramos Mejía	Buenos Aires
Argentina	Instituto Médico Río Cuarto	Río Cuarto	Córdoba
Argentina	Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica	Rosario	Santa Fe
Argentina	Clínica Mayo	San Miguel de Tucuman	Tucumán
Argentina	Go Centro Medico San Nicolás	San Nicolas	Buenos Aires
Argentina	Centro de Diagnóstico y Rehabilitación (CEDIR)	Santa Fe
Argentina	Sanatorio Norte	Santiago del Estero
Mexico	Investigacion En Salud Y Metabolismo Sc	Chihuahua
Mexico	Instituto de Diabetes, Obesidad y Nutricion	Cuernavaca	Morelos
Mexico	Diseno y Planeacion en Investigacion Medica	Guadalajara	Jalisco
Mexico	Instituto Jalisciense de Investigacion en Diabetes y Obesidad	Guadalajara	Jalisco
Mexico	Medical Care and Research SA de CV	Merida	Yucatán
Mexico	RM Pharma Specialists	Mexico City	Distrito Federal
Mexico	Hospital Universitario "Dr. Jose Eleuterio Gonzalez"	Monterrey	Nuevo León
Mexico	Hospital Universitario "Dr. Jose Eleuterio Gonzalez"	Monterrey	Nuevo León
Mexico	Unidad Médica para la Salud Integral	San Nicolás de los Garza	Nuevo León
Puerto Rico	Ponce Medical School Foundation Inc.	Ponce
Puerto Rico	Latin Clinical Trial Center	San Juan
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado
United States	Cahaba Research	Birmingham	Alabama
United States	WR-Clinsearch, LLC	Chattanooga	Tennessee
United States	Clinical Research of West Florida, Inc. (Clearwater)	Clearwater	Florida
United States	Private Practice - Dr. Osvaldo A. Brusco	Corpus Christi	Texas
United States	Dallas Diabetes Research Center	Dallas	Texas
United States	AMCR Institute	Escondido	California
United States	Decpa, Llc	Feasterville-Trevose	Pennsylvania
United States	Prime Revival Research Institute	Flower Mound	Texas
United States	American Health Network of Indiana, LLC - Franklin	Franklin	Indiana
United States	Center for Advanced Research & Education	Gainesville	Georgia
United States	Velocity Clinical Research, Gardena	Gardena	California
United States	Pacific Diabetes & Endocrine Center	Honolulu	Hawaii
United States	Endocrine Associates	Houston	Texas
United States	Endocrine Ips, Pllc	Houston	Texas
United States	National Research Institute - Huntington Park	Huntington Park	California
United States	National Research Institute - Wilshire	Los Angeles	California
United States	Suncoast Research Group	Miami	Florida
United States	American Health Network of Indiana, LLC - Muncie	Muncie	Indiana
United States	Mid Hudson Medical Research	New Windsor	New York
United States	Intend Research, LLC	Norman	Oklahoma
United States	North Hills Family Medicine/North Hills Medical Research	North Richland Hills	Texas
United States	University Of Nebraska Medical Center	Omaha	Nebraska
United States	Diabetes Associates Medical Group	Orange	California
United States	Office 18	Pittsburgh	Pennsylvania
United States	Eastside Research Associates	Redmond	Washington
United States	Syed Research Consultants Llc	Sheffield	Alabama
United States	Encompass Clinical Research	Spring Valley	California
United States	Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative	Springfield	Illinois
United States	Clinvest Research LLC	Springfield	Missouri
United States	Clinical Research of West Florida	Tampa	Florida
United States	Millennium Clinical Trials	Thousand Oaks	California
United States	Arcturus Healthcare , PLC, Troy Internal Medicine Research Division	Troy	Michigan
United States	University Clinical Investigators, Inc.	Tustin	California
United States	Meridian Clinical Research, LLC	Vestal	New York
United States	Diablo Clinical Research, Inc.	Walnut Creek	California
United States	Chase Medical Research, LLC	Waterbury	Connecticut
United States	Texas Valley Clinical Research	Weslaco	Texas
United States	Iowa Diabetes and Endocrinology Research Center	West Des Moines	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Argentina,  Mexico,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Hemoglobin A1c (HbA1c)	Demonstrate noninferiority of insulin efsitora alfa compared to insulin glargine	Baseline, Week 52
Secondary	Change from Baseline in HbA1c	Demonstrate superiority of insulin efsitora alfa compared to insulin glargine	Baseline, Week 52
Secondary	Change from Baseline in Fasting Glucose	Change from baseline in fasting glucose measured by self-monitoring blood glucose (SMBG)	Baseline, Week 52
Secondary	Level 2 and 3 Hypoglycemia Event Rate of Composite and Incidence	Incidence and rate of composite of Level 2 and 3 hypoglycemia events during the treatment period.	Week 52
Secondary	Level 2 and 3 Nocturnal Hypoglycemia Event Rate of Composite and Incidence	Incidence and rate of composite of Level 2 and 3 hypoglycemia events during the treatment period.	Week 52
Secondary	Change from Baseline in Body Weight		Baseline, Week 52
Secondary	Change from Baseline in Diabetes Treatment Satisfaction Questionnaire-Status Version (DTSQ) in Overall Treatment Satisfaction	DTSQ assesses the overall treatment satisfaction and perceived frequency of hyperglycemia and hypoglycemia.	Baseline, Week 52
Secondary	Change from Baseline in Treatment-Related Impact Measure - Diabetes (TRIM-D)	TRIM-D assesses the impact of diabetes treatment on participants' functioning and well-being across available diabetes treatments.	Baseline, Week 52
Secondary	Change from Baseline in Treatment Experience in Simplicity of Diabetes Treatment Questionnaire (SIM-Q) in Overall Simplicity and Complexity	SIM-Q assess the simplicity and complexity of treatment for type 2 diabetes (single medication).	Baseline, Week 52
Secondary	Change from Baseline in Treatment Experience in Diabetes Injection Device Experience Questionnaire (DID-EQ) in Device Characteristics	DID-EQ assesses participants' perceptions of non-insulin diabetes injection delivery systems for type 2 diabetes.	Baseline, Week 52

External Links

•   A Study of LY3209590 Compared to Glargine in Adult Participants With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time (QWINT-1)